Safety and Efficacy of a Unique Dose of a Brown Seaweeds Powder Enriched in Polyphenols on Human
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Safety of a single 500 mg administration of a brown seaweed extract in human
研究概览
简要总结
The primary endpoint of this trial will be to evaluate the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal. The secondary endpoint of this trial will be to evaluate if a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder is able to reduce the rate of carbohydrate absorption as measured by following postprandial glycemia and insulinemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
- •BMI between 20 and 30
- •Non-smoking
排除标准
- •Iodine allergy
- •Use of dietary supplements for duration of study
- •History of major surgeries or surgeries of the stomach or digestive tract
研究组 & 干预措施
Treatment
Single administration of 500 mg of encapsulated brown seaweed powder, taken 30 minutes before test meal
干预措施: Brown seaweed powder (Dietary Supplement)
Placebo
Single administration of encapsulated placebo, taken 30 minutes before test meal
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Safety of a single 500 mg administration of a brown seaweed extract in human
时间窗: First administration up to 7 days after last administration
次要结局
- Significant reduction of glycemic index of test food(Immediately after product administration (single use))
- Significant reduction in postprandial glycemia(Immediately after product administration (single use))
- Significant reduction in postprandial insulinemia(Immediately after product administration (single use))